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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Hernia (2240)
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Event Type
Injury
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Event Description
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This report is being filed after the subsequent review of the following journal article: galan, t.V., et al (2012).Case report: incisional hernia as a complication of extreme lateral interbody fusion.The spine journal, 12, p.E1-e6.This was retrospective review of a case report in which the purpose was to report the rare complication of an incisional hernia after minimal access lateral transpsoas approach for lumbar interbody fusion.The case report involved one (b)(6) female with a history of low back and left lower extremity pain.Imaging studies results: grade i spondylolisthesis of l4 on l5 with resultant ventral and foraminal stenosis.She tried and failed non-operative treatment including epidural injections and pain medications.Patient had a lateral and posterior spinal fusion via lateral access approach interbody fusion at l4-5 with oracle, with l4-5 posterior spinal fusion with constellation instrumentation via percutaneous mis technique.Four weeks after surgery, patient had tender prominence over lateral surgical incision on flank and later diagnosed with a hernia (based on ct scan).She had laparoscopic repair and was able to resume normal activities.This report is 1 of 2 for (b)(4).This report is for an unknown oracle.
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Manufacturer Narrative
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Galan, t.V., et al (2012).Case report: incisional hernia as a complication of extreme lateral interbody fusion.The spine journal, 12, p.E1-e6.This report is for unknown oracle/unknown quantity/unknown lot.(b)(6).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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